Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118053
Status:
TERMINATED
Last Update Posted:
2013-11-20
First Post:
2005-07-08
Brief Title:
Trastuzumab Docetaxel and Carboplatin in Treating Women With Stage II Stage III or Inflammatory Breast Cancer
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Phase II Trial of Taxotere Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Drugs used in chemotherapy such as docetaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells
PURPOSE This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II stage III or inflammatory breast cancer
PURPOSE This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II stage III or inflammatory breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of trastuzumab Herceptin docetaxel and carboplatin as measured by tumor response rate in women with previously untreated HER2neu-positive stage IIB IIIA IIIB or IIIC or inflammatory breast cancer
Secondary
Determine the pathological complete response in patients treated with this regimen
Determine the disease-free survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine pathologic and molecular markers for predicting efficacy of this regimen in these patients
OUTLINE This is a non-randomized multicenter study
Course 1 days 1-28 Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 8
Course 2-6 Patients receive trastuzumab IV over 30 minutes on days 1 8 and 15 during courses 2-5 and on days 1 8 15 and 22 during course 6 Patients also receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 21 days for 5 additional courses 6 courses total in the absence of disease progression or unacceptable toxicity
Three weeks after completion of course 6 patients undergo restaging Patients with local operable disease undergo modified radical mastectomy or lumpectomy and axillary node dissection followed by radiotherapy Patients also receive trastuzumab IV once every 3 weeks for up to 52 weeks of total treatment including the 6 courses of trastuzumab docetaxel and carboplatin in the absence of disease progression or unacceptable toxicity Patients who do not have local operable disease continue to receive trastuzumab as above
PROJECTED ACCRUAL A total of 13-43 patients will be accrued for this study
Primary
Determine the antitumor activity of trastuzumab Herceptin docetaxel and carboplatin as measured by tumor response rate in women with previously untreated HER2neu-positive stage IIB IIIA IIIB or IIIC or inflammatory breast cancer
Secondary
Determine the pathological complete response in patients treated with this regimen
Determine the disease-free survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine pathologic and molecular markers for predicting efficacy of this regimen in these patients
OUTLINE This is a non-randomized multicenter study
Course 1 days 1-28 Patients receive trastuzumab Herceptin IV over 30-90 minutes on days 1 8 15 and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 8
Course 2-6 Patients receive trastuzumab IV over 30 minutes on days 1 8 and 15 during courses 2-5 and on days 1 8 15 and 22 during course 6 Patients also receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1 Treatment repeats every 21 days for 5 additional courses 6 courses total in the absence of disease progression or unacceptable toxicity
Three weeks after completion of course 6 patients undergo restaging Patients with local operable disease undergo modified radical mastectomy or lumpectomy and axillary node dissection followed by radiotherapy Patients also receive trastuzumab IV once every 3 weeks for up to 52 weeks of total treatment including the 6 courses of trastuzumab docetaxel and carboplatin in the absence of disease progression or unacceptable toxicity Patients who do not have local operable disease continue to receive trastuzumab as above
PROJECTED ACCRUAL A total of 13-43 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CINJ-NJ1104 | OTHER | Cancer Institute of New Jersey | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| CINJ-040412 | OTHER | None | None |
| 0220045191 | OTHER | None | None |